• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

W. L. GORE & ASSOCIATES, INC. GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT Back to Search Results
Catalog Number ECH060040
Device Problems Peeled/Delaminated (1454); Obstruction of Flow (2423)
Patient Problem Obstruction/Occlusion (2422)
Event Date 12/03/2021
Event Type  malfunction  
Event Description
It was reported to gore that the patient underwent surgical treatment for a dialysis shunt in the left forearm with a gore® acuseal vascular graft.It was stated that the vascular graft was implanted on (b)(6) 2021, as a loop shunt for av access.On (b)(6) 2021, the shunt occluded.The physician stated that a delamination of the graft appeared to be seen.The graft remained implanted.Reportedly, the patient received a central venous line and is treated in the (b)(6).
 
Manufacturer Narrative
As the device remains implanted, no further investigation of the device can be performed.An image was provided for further evaluation.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
 
Manufacturer Narrative
Product history review: a review of the manufacturing - and heparin coatings records indicated the lots met all pre-release specifications.As the device remains implanted, no further investigation of the device can be performed.Imaging evaluation: the image provided by the complainant reflects the case description but could not be confirmed.The evaluation found no anomalies attributable to the manufacture of the device.With the information provided to gore, the cause of the reported issue could not be established.In the instruction for use for the gore® acuseal vascular graft the following is stated: technical information: patients should be carefully monitored when using gore® acuseal vascular grafts for vascular access.Puncture sites must be adequately separated when repeated needle punctures of the graft are necessary.Multiple punctures in the same area may lead to disruption of the graft material or formation of a perigraft hematoma or pseudoaneurysm.Possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: thrombosis; mechanical disruption, formation of pseudoaneurysms due to excessive, localized, or large needle punctures.
 
Manufacturer Narrative
H6: evaluation codes medical device problem code a040506 was added.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GORE® ACUSEAL VASCULAR GRAFT
Type of Device
PROSTHESIS, VASCULAR GRAFT
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MEDICAL WEST B/P
1505 n. fourth street
flagstaff AZ 86004
Manufacturer Contact
gunter marte
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key14742728
MDR Text Key295351950
Report Number2017233-2022-03021
Device Sequence Number1
Product Code DSY
Combination Product (y/n)Y
Reporter Country CodeNL
PMA/PMN Number
K130215
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/04/2023
Device Catalogue NumberECH060040
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/30/2022
Initial Date FDA Received06/20/2022
Supplement Dates Manufacturer Received06/29/2022
11/02/2022
Supplement Dates FDA Received07/28/2022
11/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age45 YR
Patient SexMale
-
-